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Clinical Evaluation of Dimethyl Sulfoxide Dentin Pre-treatment

Primary Purpose

Dental Diseases

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dimethyl Sulfoxide
3M ESPE Single bond 2
Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA)
3m ESPE etch
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Diseases focused on measuring DMSO

Eligibility Criteria

16 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with cervical lesions.
  • Co-operative patients approving to participate in the study.
  • Pulp is asymptomatic vital teeth.
  • Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

Exclusion Criteria:

  • Xerostomia.
  • Bruxism and visible wear facets in the posterior dentition.
  • Known inability to return for recall appointments.
  • Fractured or visibly cracked candidate tooth.
  • Current desensitizing therapy, including desensitizing dentifrices or other over-the-counter (OTC) products.
  • Long-term use of anti-inflammatory, analgesic, or psychotropic drugs.
  • Pregnancy or breastfeeding (potential conflicts with recall dates.
  • Allergies to ingredients of resin-based restorative materials.
  • Orthodontic appliance treatment within the previous three months.
  • Abutment teeth for fixed or removable prostheses.
  • Teeth or supporting structures with any symptomatic pathology.
  • Existing periodontal disease or periodontal surgery within the previous three months.

Sites / Locations

  • Faculty of Dentistry, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

3M single bond, etch and rinse adhesive

DMSO pre-treatment before 3M single bond application

Arm Description

O.I. will clean the labial surface of tooth with polishing paste and brush Roughening of the surface may be needed by diamond point The tooth will be isolated by rubber dam. Apply etchant for 30 s for enamel and 15 s for dentin. Rinse thoroughly with water for 10 s. blot-drying with paper tissue was carefully performed leaving the dentin surface slightly moist. Apply 2 to 3 consecutive coats of the adhesive for 15 s. Gently air for 5 s. Light cure for 10 s. Composite build ups (Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA) were performed in increments and individually light-cured for 40 s. Light curing of all resin materials was performed using a LED device (Bluephase 20i, Ivoclare Vivadent, Schaan, Liechtenstein) delivering 1100 mW/cm2.

The same steps of the comparator group with additional step, after dentin etching and humidity control, dentin pretreatments were performed consisting of active application of 1% DMSO/H2O solutions on etched-dentin followed by blot drying until paper filters no longer absorbed liquids from the bonding surface by capillarity then apply adhesive.

Outcomes

Primary Outcome Measures

Biological (change of caries adjacent to the restoration)
FDI criteria for evaluation of restorations, percentage score. Score: Properties Clinically excellent/ very good: No secondary or primary caries. Clinically good: Small and Localized 1. Demineralization, 2. Erosion or 3. Abfraction. Clinically sufficient/satisfactory: Larger areas Of 1. Demineralization, 2. Erosion or 3. Abrasion/abfraction, dentine not exposed. Clinically unsatisfactory: Caries with Cavitation and suspected undermining caries, 2. Erosion in dentine, 3. Abrasion/ abfraction in dentine. Clinically poor: Deep caries or exposed dentine that is not accessible for repair of restoration.

Secondary Outcome Measures

Functional (change of marginal adaptation)
FDI criteria for evaluation of restorations, percentage score. Score: Properties. Clinically excellent/ very good: Harmonious outline, no gaps, no white or discolored lines. Clinically good: Marginal gap (<150 µm), White lines. Or Small marginal fracture removable by polishing. or Slight ditching, slight step/flashes, minor Irregularities. Clinically sufficient/satisf actory: Gap < 250 µm not removable. Or Several small marginal fractures. Or Major irregularities, ditching or flash, steps. Clinically unsatisfactory: Gap > 250 µm or dentine/base exposed. Or Severe ditching or marginal fractures. or Larger irregularities or steps (repair necessary). Clinically poor: Restoration (complete or partial) is loose but in situ. Or Generalized major gaps or irregularities.

Full Information

First Posted
July 22, 2020
Last Updated
February 8, 2023
Sponsor
Cairo University
Collaborators
University of Turku
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1. Study Identification

Unique Protocol Identification Number
NCT04492306
Brief Title
Clinical Evaluation of Dimethyl Sulfoxide Dentin Pre-treatment
Official Title
In Vivo Clinical Evaluation of Dimethyl Sulfoxide Dentin Pre-treatment Prior to a Two-step Etch and Rinse Adhesive: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 17, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
University of Turku

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is conducted in order to evaluate the clinical effectiveness of 1% DMSO dentin pre-treatment on the clinical performance of etch and rinse adhesive.
Detailed Description
Despite substantial advances in resin-dentin bonding over the past decades, reduction in bonding effectiveness of currently available dental adhesives remains a major limitation in modern adhesive dentistry. Hydrolysis of both organic and resin constituents of hybrid layer persists as impediments in dentin bonding longevity. Since bonding is directly related to the quality of the formed polymer the resin components play an important role in proper resin-dentin interaction and in the mechanical properties of the material. In face of the limitations of most current clinically-feasible bonding protocols and inherent drawbacks of the etch-and-rinse approach an ideal resin-enveloped collagen scaffold is unlikely to be produced in a consistent manner. In dentin hybridization, adhesive infiltration is far from perfect resulting in poorly formed hybrid layers. Replacement of all 70 vol% residual water in etched-dentin with monomers is hardly achieved. For this reason, the hybrid layer may be considered as the weak link in resin-dentin bonds. DMSO [(CH3)2SO] is a polar aprotic solvent that dissolves both polar and non-polar compounds. It is a polyfunctional molecule, with a highly polar S O group and two hydrophobic methyl groups, fully miscible in most solvents and monomers used in adhesive dentistry. DMSO is perhaps the best currently known penetration enhancer for medical purposes with the ability to dissociate the highly crosslinked collagen into a sparser network of apparent fibrils. The rationale for testing a bonding resin with relatively low DMSO-content is that incorporation of high DMSO concentrations may hamper the mechanical properties of dimethacrylate bonding polymers, which in turn could compromise the bonded interface. DMSO's ability to "biomodify" collagen structure, increasing spaces between collagen microfibrils and improving dentin wettability support the improved bonding effectiveness even under dry-conditions. It is evident that this simplified use of DMSO or, to a better extent, its use as a dentin pretreatment reduced technique sensitivity of the etch-and-rinse approach concomitantly allowing water removal from the bonded interface by the proposed dry-bonding technique. Optimized bonding efficiency combined with reduced water-content during dentin hybridization could greatly contribute to clinical long-term durability. Nevertheless, further studies are necessary to test such hypothesis. Specially that there is no clinical study support this theory yet even DMSO had taken the FDA approval many years ago as a pharmaceutical solvent and has been used in several medications. DMSO caused no or minor cytotoxic effects on the pulp tissue repair-related activity of odontoblast-like cells.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Diseases
Keywords
DMSO

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
In our clinical trial double blinding will be performed, the participants and both assessors (H.M.& N.H.) will be blinded to the type of the material used to reduce performance and ascertainment bias and also reduce biased estimates of treatment effects. The operator cannot be blinded in this trial because of the difference in the application procedures of each restorative material. Therefore, the operator (O.I.) will take care to treat the two allocation groups as equally as possible by standardizing the care of participants, frequency of follow-ups and management of complications.
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3M single bond, etch and rinse adhesive
Arm Type
Active Comparator
Arm Description
O.I. will clean the labial surface of tooth with polishing paste and brush Roughening of the surface may be needed by diamond point The tooth will be isolated by rubber dam. Apply etchant for 30 s for enamel and 15 s for dentin. Rinse thoroughly with water for 10 s. blot-drying with paper tissue was carefully performed leaving the dentin surface slightly moist. Apply 2 to 3 consecutive coats of the adhesive for 15 s. Gently air for 5 s. Light cure for 10 s. Composite build ups (Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA) were performed in increments and individually light-cured for 40 s. Light curing of all resin materials was performed using a LED device (Bluephase 20i, Ivoclare Vivadent, Schaan, Liechtenstein) delivering 1100 mW/cm2.
Arm Title
DMSO pre-treatment before 3M single bond application
Arm Type
Experimental
Arm Description
The same steps of the comparator group with additional step, after dentin etching and humidity control, dentin pretreatments were performed consisting of active application of 1% DMSO/H2O solutions on etched-dentin followed by blot drying until paper filters no longer absorbed liquids from the bonding surface by capillarity then apply adhesive.
Intervention Type
Other
Intervention Name(s)
Dimethyl Sulfoxide
Other Intervention Name(s)
1% DMSO
Intervention Description
DMSO [(CH3)2SO] is a polar aprotic solvent that dissolves both polar and non-polar compounds.
Intervention Type
Other
Intervention Name(s)
3M ESPE Single bond 2
Intervention Description
Total etch adhesive bond
Intervention Type
Other
Intervention Name(s)
Filtek Z350 XT, 3 M ESPE, St Paul, MN, USA)
Intervention Description
Composite Resin
Intervention Type
Other
Intervention Name(s)
3m ESPE etch
Intervention Description
32% phosphoric acid
Primary Outcome Measure Information:
Title
Biological (change of caries adjacent to the restoration)
Description
FDI criteria for evaluation of restorations, percentage score. Score: Properties Clinically excellent/ very good: No secondary or primary caries. Clinically good: Small and Localized 1. Demineralization, 2. Erosion or 3. Abfraction. Clinically sufficient/satisfactory: Larger areas Of 1. Demineralization, 2. Erosion or 3. Abrasion/abfraction, dentine not exposed. Clinically unsatisfactory: Caries with Cavitation and suspected undermining caries, 2. Erosion in dentine, 3. Abrasion/ abfraction in dentine. Clinically poor: Deep caries or exposed dentine that is not accessible for repair of restoration.
Time Frame
Day 0, Month 6, Month 12, Month 18
Secondary Outcome Measure Information:
Title
Functional (change of marginal adaptation)
Description
FDI criteria for evaluation of restorations, percentage score. Score: Properties. Clinically excellent/ very good: Harmonious outline, no gaps, no white or discolored lines. Clinically good: Marginal gap (<150 µm), White lines. Or Small marginal fracture removable by polishing. or Slight ditching, slight step/flashes, minor Irregularities. Clinically sufficient/satisf actory: Gap < 250 µm not removable. Or Several small marginal fractures. Or Major irregularities, ditching or flash, steps. Clinically unsatisfactory: Gap > 250 µm or dentine/base exposed. Or Severe ditching or marginal fractures. or Larger irregularities or steps (repair necessary). Clinically poor: Restoration (complete or partial) is loose but in situ. Or Generalized major gaps or irregularities.
Time Frame
Day 0, Month 6, Month 12, Month 18
Other Pre-specified Outcome Measures:
Title
Esthetic (Color match and translucency)
Description
FDI criteria for evaluation of restorations, percentage score. Score: Properties Clinically excellent/ very good: Good color match, no difference in shade and/or translucency. Clinically good: Minor deviations in shade and/or translucency. Clinically sufficient/satisfactory: Distinct deviation but acceptable. Does not affect esthetics: 1. more opaque ,2. more translucent ,3. darker,4. brighter. Clinically unsatisfactory: Localized clinically deviation that can be corrected by repair: 1.Too opaque, 2.Too translucent,3. Too dark, 4.Too bright. Clinically poor: Unacceptable. Replacement necessary.
Time Frame
Day 0, Month 6, Month 12, Month 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with cervical lesions. Co-operative patients approving to participate in the study. Pulp is asymptomatic vital teeth. Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth. Exclusion Criteria: Xerostomia. Bruxism and visible wear facets in the posterior dentition. Known inability to return for recall appointments. Fractured or visibly cracked candidate tooth. Current desensitizing therapy, including desensitizing dentifrices or other over-the-counter (OTC) products. Long-term use of anti-inflammatory, analgesic, or psychotropic drugs. Pregnancy or breastfeeding (potential conflicts with recall dates. Allergies to ingredients of resin-based restorative materials. Orthodontic appliance treatment within the previous three months. Abutment teeth for fixed or removable prostheses. Teeth or supporting structures with any symptomatic pathology. Existing periodontal disease or periodontal surgery within the previous three months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randa Hafez, Professor
Organizational Affiliation
Cairo U
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Cairo
ZIP/Postal Code
12613
Country
Egypt

12. IPD Sharing Statement

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Clinical Evaluation of Dimethyl Sulfoxide Dentin Pre-treatment

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